ARPIMED LLCHead of Quality Assurance Department
May. 2013 - Mar. 2017c. Abovyan, 2204, Republic of Armenia1. Developed and implemented the Quality department’s strategy, to ensure it met the business requirements and customer deliverables, as well as ensured the departmental performance against goals. 2. Implemented and monitored all Quality Assurance systems to ensure compliance with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use.
3. Acted as the main point of contact on all Quality matters, internally and externally.
4. Managed all validation activities, including validation strategy and approval of protocols and reports.
5. Ensured appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved).
6. Wrote SOPs, reviewed batch records and handled deviations, complaints, CAPAs and change controls.